Filter Results

Clinical Studies

Open

  • A Double Blind, Randomised, Placebo-controlled Trial Evaluating The Efficacy And Safety Of Nerandomilast Over At Least 26 Weeks In Patients With Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases (SARD-ILD) Scottsdale/Phoenix, AZ Rochester, MN Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease.

    Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease.

    Participants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
  • A Phase 1 Study Evaluating The Safety And Preliminary Efficacy Of ALLO-329, A Dual Anti-CD19/Anti-CD70 Allogeneic CAR T Cell Product In Autoimmune Disease (RESOLUTION) Scottsdale/Phoenix, AZ This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).
  • Assessing and validating the psychometric properties of the CRISTAL PRO through an online registry Scottsdale/Phoenix, AZ

    The purpose of this study is to validate the CRISTAL patient-reported outcome (PRO) where patients will complete PROs at baseline and again at 6 months. The PRO includes survey items designed to assess limited cutaneous systemic sclerosis (lcSSc) symptoms and experiences from a patient perspective. 

Contact Us for the Latest Status

  • A Phase 1 Study Evaluating The Safety And Preliminary Efficacy Of ALLO-329, A Dual Anti-CD19/Anti-CD70 Allogeneic CAR T Cell Product In Autoimmune Disease (RESOLUTION) Jacksonville, FL This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).
.